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Subject:
From:
"Kermaline J. Cotterman" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Thu, 15 Jan 2004 02:53:57 -0500
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The recent LN discussions on Domperidone and Trivisol made me notice this
abstract from Medscape this week. I thought it might be of interest to
others:

The Political Economy of FDA Drug Review: Processing, Politics and
Lessons for Policy
Posted 01/07/2004

Daniel P. Carpenter

Abstract and Introduction
Abstract
U.S. Food and Drug Administration (FDA) drug review bears a structural
similarity to many decisions made by other regulatory agencies: high
uncertainty, low reversibility, avoidance of observable error, and high
political stakes that induce lobbying by interested parties. This paper
explores the policy lessons to be learned from viewing FDA drug review as
a politically shaped exercise in information processing. I argue that the
incentives facing regulators induce limits on the degree to which drug
review can be accelerated, that the same incentives could render
privatization initiatives problematic, and that political pressures could
play a useful role in identifying priority drugs.>

Jean
************
K. Jean Cotterman RNC, IBCLC
Dayton, Ohio USA

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